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Genentech snags a PhII-ready IL-33 asthma/COPD drug from Amgen
FierceBiotech Genentech, though, appears to be out front with its new antibody–which Amgen had dubbed AMG 282–now headed into Phase II for asthma and COPD as investigators set out to see if they can control the diseases by shutting down the IL-33 pathway. |
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Fox News |
FDA experts endorse Teva's asthma drug, but reject use in key patient group
FierceBiotech An FDA advisory panel has handed Teva ($TEVA) a ringing endorsement for its IL-5 asthma drug reslizumab, offering a unanimous recommendation for marketing approval. That recommendation should quickly put it in direct rivalry with GlaxoSmithKline … FDA advisers recommend approval of Teva asthma drug in adults US FDA advisers recommend approval of Teva asthma drug for adults FDA Advisory Committee Recommends Approval of Teva's Asthma Biologic Reslizumab |
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Medscape |
GlaxoSmithKline's new asthma drug gets a split vote from FDA advisers
FierceBiotech GSK's injection, mepolizumab, works by blocking the protein interleukin-5 to prevent buildups of white blood cells in the lungs that can exacerbate asthma. The company is angling to get the drug approved as a treatment for sufferers of severe asthma … FDA Panel Backs Mepolizumab for Severe Eosinophilic Asthma GlaxoSmithKline plc (ADR) Wins FDA Panel Backing For Severe Asthma Drug Asthma Drug Targeting IL-5 Wins Partial Backing From FDA Advisers |
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Regeneron speeds toward the FDA with its would-be asthma blockbuster
FierceBiotech Meanwhile, after meeting with the FDA, Regeneron now believes the agency will recognize an earlier Phase IIb asthma study as one of two required pivotal trials. In that trial, the highest doses of dupilumab significantly beat out placebo in improving … Regeneron and Sanofi Announce Positive Pivotal Phase 2b Dupilumab Data in … |
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Amgen, AstraZeneca prep a brodalumab pitch–after scuttling asthma program
FierceBiotech Amgen and its partner AstraZeneca are winding up to deliver U.S. and European applications for their big blockbuster hopeful brodalumab for plaque psoriasis by mid-year. But their last shot to push ahead with the drug in asthma ran into defeat, with … |
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Reuters |
Promising asthma trial prompts Regeneron, Sanofi to push dupilumab into PhIII
FierceBiotech Regeneron and its close partner Sanofi have cleared the final mid-stage hurdle for dupilumab in asthma patients, with several doses hitting the trial endpoint both for a subset of patients as well as the broad population. And the ambitious development … Sanofi's dual-action biotech asthma drug performs well in test Positive results for Sanofi/Regeneron's dupilumab in asthma |
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AstraZeneca gets some upbeat asthma data to back would-be IL-5 blockbuster
FierceBiotech Benralizumab–an IL-5 antibody–reduced the rate of asthma exacerbations, hitting the primary endpoint in the trial, says AstraZeneca ($AZN). But the study flagged weak results for the low end of the doses used in the trial, with the top dose doing … AstraZeneca share price: Novel drug shows positive results for severe asthma AstraZeneca's benralizumab succeeds in severe asthma |
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Reuters India |
A respiratory expert undermines GSK's case for new asthma drug mepolizumab
FierceBiotech Investigators for GlaxoSmithKline ($GSK) detailed their promising Phase III data for the IL-5 biologic mepolizumab in asthma today, noting that the injectable halved the rate of exacerbations among a group of patients with uncontrolled cases of the … UPDATE 1-Cost a focus as GSK takes lead in new wave of biotech lung drugs |
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Globes |
Teva's well-traveled asthma drug comes through in Phase III
FierceBiotech The drug, which works by blocking the interleukin-5 pathway, met its primary endpoints in two Phase III studies on patients with inadequately controlled asthma and elevated levels of inflammatory white blood cells, Teva said. In 12-month data from more … Teva finds positive results in advanced trials for asthma drug Teva's Reslizumab Shows Reduction In Asthma Exacerbations In Clinical Studies Teva stakes its claim to the asthma antibody market |
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Bidness Etc |
GlaxoSmithKline grabs FDA approval for its latest asthma treatment
FierceBiotech "The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio," Senior Vice President Darrell Baker said in a statement. "It is the first asthma treatment from our new portfolio to have gained approval in … GSK's Asthma Treatment Gets FDA Approval FDA OKs New Maintenance Asthma Treatment Arnuity Ellipta FDA approves GSK asthma medicine |
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